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23-222-115

OraSure Technologies InteliSwab™ COVID-19 Rapid Test, OTC

Manufacturer: OraSure Technologies

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CE Marker

No

Detectable Analytes

SARS-CoV-2 Nucleocapsid Protein Antigen

Sensitivity

84%

Includes

Security Chip

Clia Complexity

Waived (OTC)

Sample Type

Anterior Nasal Swab

Type

COVID-19 Rapid Antigen Test

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Description

  • Self-collected, visual read lateral flow test Both symptomatic and asymptomatic use Intuitive workflow: just swab, swirl, and see Workflow requires < 1 minute of active, hands-on time; 30-minute time to result Gentle lower nasal swab Overall test performance: Positive Percent Agreement 84%, Negative Percent Agreement 98% No precise number of drops required

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